Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

New Legal Framework for Food for Special Medical Purposes - Implications on Demarcation and Regulatory Requirements at European Level and in Germany ***

Mareike Gleissner (Abschlußjahr: 2018)

Summary
Food for special medical purposes (FSMP) is vital for the patients for whom it is intended, in order to guard against disease-related malnutrition and its consequences. As a legal category in the borderline between food for normal consumption and medicinal products, FSMP became a trend in the food and the pharmaceutical industry. However, since the previous legislation covering FSMP resulted in inconsistent application across Member States, it has recently been replaced with a new, harmonised framework law.
This thesis illustrates how Regulation (EU) No 609/2013, supplemented by Delegated Regulation (EU) 2016/128 and relevant guidelines, impacts the demarcation of FSMP and regulatory requirements applicable to it in comparison to previous provisions at EU level and in Germany. The intention of this work is to analyse relevant changes that need to be considered when placing FSMP on the market, and to discuss legal difficulties that frequently arise amongst stakeholders, in particular in terms of correct classification.
The findings reveal that distributors and national competent authorities are still left with much flexibility and legal uncertainty, which indicates that differences in the interpretation of the law are likely to last. However, a newly introduced legal act that involves a centralised evaluation of data through EFSA may contribute to more harmonised decisions on notified products in future. While options to advertise FSMP clearly are further restricted, more concrete details on appropriate compositions or scientific evidence required are not ruled.
The demarcation continues to be difficult in borderline cases since ‘pharmacological activity’ which is to be exclusively reserved for medicinal products has not yet been legally defined. Due to minor changes, an indirect requirement for FSMP dossiers may result as a consequence of the new legal environment, while distributors retain with the responsibility to decide the correct classification and the exact scientific data required, also taking into account ongoing developments of scientific research and court judgments.
Pages: 66
Annex: 6, Pages: 10